US20050197646A1 - Dialysis connector with retention and feedback features - Google Patents
Dialysis connector with retention and feedback features Download PDFInfo
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- US20050197646A1 US20050197646A1 US11/046,306 US4630605A US2005197646A1 US 20050197646 A1 US20050197646 A1 US 20050197646A1 US 4630605 A US4630605 A US 4630605A US 2005197646 A1 US2005197646 A1 US 2005197646A1
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- connectors
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- shell
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/285—Catheters therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/282—Operational modes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
- A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1044—Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
Definitions
- the present invention relates generally to medical treatments. More specifically, the present invention relates to medical connectors for use in medical treatments, such as Peritoneal Dialysis (“PD”).
- PD Peritoneal Dialysis
- urea urea, creatinine, uric acid, and others
- Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body that would otherwise have been removed by normal functioning kidneys. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is life saving. One who has failed kidneys could not continue to live without replacing at least the filtration functions of the kidneys.
- PD uses a dialysis solution or dialysate, which is infused into a patient's peritoneal cavity.
- the dialysate contacts the patient's peritoneal membrane in the peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate.
- the transfer of waste, toxins, and water from the bloodstream into the dialysate occurs by diffusion and osmosis because there is an osmotic gradient across the peritoneal membrane.
- the spent dialysate is drained from the patient's peritoneal cavity to remove the waste, toxins and water from the patient. New dialysate replaces the spent dialysate and the process repeats.
- a dialysis fluid exchange generally includes draining spent dialysis fluid from the peritoneal cavity and filling the peritoneal cavity with fresh dialysate. Keeping track of the amounts or volumes of dialysis solution drained from and supplied to the peritoneal cavity is important for proper dialysis therapy. A typical amount of dialysate solution drained from and supplied to the peritoneal cavity of an adult during an exchange can be roughly two to three liters. Dialysis fluid exchanges have been performed manually, usually by the patient, or automatically, by an automated dialysis machine.
- a catheter is implanted into the peritoneal cavity of the patient.
- a dialysis solution (“dialysate”) is introduced through the catheter into the peritoneal cavity of a patient.
- a container of the dialysate connects to a connector, which in turn couples to the catheter.
- a clamp on a tube connecting the container to the connector is loosened or a valve is opened.
- the container is located vertically above the patient and gravity fed into the peritoneal cavity.
- dialysis machines use one or more fluid pumps to perform the dialysate exchanges.
- the pump pumps spent dialysate fluid out of the peritoneal cavity during the drain mode and pumps dialysate into the cavity during the fill mode.
- the spent container is disconnected and discarded, wherein a new container of dialysate fluid is attached and the process is repeated. This process may be repeated several times or continuously repeated. Because many patients perform the PD (CAPD or APD) procedure themselves, it is important that the connector which connects the dialysate container to the catheter is easy to use and provides a secure connection.
- Peritonitis results if connections are made between the peritoneal catheter and the connector communicating with the dialysis container in a manner that permits even a very small number of microorganisms to enter the catheter. The microorganisms will be flushed into the peritoneal cavity. Peritonitis can occur even when extreme caution is observed in making and unmaking the connections. Peritonitis can be painful and can temporarily diminish the hydraulic permeability of the peritoneal membrane, rendering the renal treatment less successful.
- Methods to prevent peritonitis have included thoroughly cleansing the connector and the tube connecting the dialysate container before the connection is made.
- the connector can be immersed in povidone iodine, betadine or other type of disinfectant.
- povidone iodine, betadine or other type of disinfectant typically wear sterile rubber gloves to prevent or guard against any possible peritoneal invasion of bacteria.
- the spread of contamination can still occur due to, for example, a cut in the glove or other like condition.
- the present invention relates to a connector and a cap that are easily and readily attachable to a dialysate container and a catheter inserted into a patient's peritoneal cavity.
- the connector and the cap enable the dialysate to be readily transported between the container and the peritoneal cavity while minimizing the potential of contamination therein due to, for example, handling during use.
- a connector in an embodiment of the present invention, includes a shell that encloses a cap.
- the cap houses a slit septum.
- the cap also includes a sealed disinfectant within an interior receptacle.
- the seal in an embodiment is a cross-linked elastomeric seal, e.g., a silicone seal.
- the disinfectant includes a povidone iodine or PVP-I.
- the connector is also initially packaged including a tip protector that encloses the shell/cap assembly and provides a barrier to microbial contamination prior to use.
- a cap for use in a connector making a resealable fluid path includes a body that defines a fluid flow passage and a disinfectant receptacle.
- the receptacle houses the disinfectant.
- a seal is disposed within the body. The seal seals the disinfectant between the seal and the receptacle.
- the body defines an opening that receives a fluid communication member.
- the fluid communication member is capable of displacing the seal when the body receives the member.
- the disinfectant disperses between an outer wall of the fluid communication member and an inner wall of the body when the seal is displaced.
- the body defines outer threads.
- the outer threads engage mating threads of a shell and enable the shell to translate with respect to the body.
- the translating shell causes a sealed end of the body to be pierced.
- the body defines inner threads.
- the inner threads engage mating threads of a fluid communication member and enable the member to translate with respect to the body.
- the translating member causes the seal to be displaced.
- the seal is moveable.
- the body includes a tube portion that defines the fluid flow passage.
- the disinfectant receptacle resides about the tube portion.
- a portion of the passage is sized to house a member that deforms to seal about a tube.
- the member automatically closes when the tube is removed from the member.
- a connector for making a resealable fluid path includes a cap that defines a fluid flow passage.
- the cap seals an amount of disinfectant, such as a continuous quantity thereof.
- a shell moveably engages the cap.
- the shell includes a fluid communication member.
- the fluid communication member is capable of piercing a sealed end of the cap and fluidly communicating with the fluid flow passage when the shell moves with respect to the cap.
- the disinfectant includes povidone iodine.
- the connector includes a tip protector that engages the shell.
- the shell attaches to a fluid line running to a dialysate container and the cap attaches to a fluid line running to a patient.
- the sealed end of the cap includes a slit septum.
- the connector includes an elastomeric seal that seals the disinfectant about the fluid flow passage.
- a method for providing a sterile connection of a dialysate line includes providing a cap that has a passage and maintains a seal that houses a disinfectant.
- a first member connects to a first end of the cap. The first member then fluidly communicates with a first dialysate line.
- a second member connects to a second end of the cap so as to displace the seal and the disinfectant. The second member then fluidly communicates with a second dialysate line.
- connecting the first member includes moving the first member so as to pierce a sealed end of the cap, which places the first member in fluid communication with the second member.
- the sealed end of the cap seals about the first member when the first member pierces the sealed end.
- the sealed end of the cap reseals when the first member is removed from the cap.
- rupturing the seal includes threading the second member into the cap and exerting pressure on the seal.
- connecting the second member includes displacing the disinfectant between the cap and the second member.
- the method further includes maintaining the disinfectant between the cap and the second member after the seal is displaced.
- the method includes removing the first member from the cap such that the sterile connection between the cap and the second member is maintained.
- the method includes removing a tip protector and connecting the second member in place of the tip protector.
- a method for providing PD includes the steps of providing a first member in fluid communication with a dialysate container, a second member in fluid communication with a peritoneal cavity of a patient, and a cap that has a sealed first end, a second end, a passage and maintains a seal that houses a disinfectant; connecting the first member to the sealed first end of the cap; connecting the second member to the second end of the cap so as to displace the seal and the disinfectant thereby causing the first member to pierce the sealed first end of the cap; filling the peritoneal cavity with an amount of fresh dialysate fluid; and removing the first member to automatically reseal the first end of the cap.
- the method includes removing an amount of spent dialysate fluid from the peritoneal cavity prior to filling the peritoneal cavity with the fresh dialysate fluid.
- the method includes connecting another first member to the first end, removing spent dialysate fluid from the peritoneal cavity and refilling the peritoneal cavity with fresh dialysate fluid.
- the filling and removing steps are performed manually or automatically.
- the end of the transfer set or member that moves the seal to displace the disinfectant is contoured to break or move the seal readily so that the seal may be provided and maintained without too much difficulty.
- the seal is configured to retain the disinfectant under extreme conditions of steam or other type of sterilization technique, but which will also rupture easily to displace disinfectant when needed.
- the transfer set end or member that moves or ruptures the seal is contoured so that the force necessary to move the seal fully to displace the disinfectant fully is reduced. Also, the tendency of the seal to adhere to the end of the transfer set or member is lessened.
- a shell of the dialysis connector e.g., leading from the dialysis supply
- a portion of the transfer set leading from the patient
- Such features help to ensure that the connector and transfer set are tightened enough but not overly tightened.
- the features can also provide audio, visual and/or tactile feedback to the patient so that the patient knows when it is safe to stop attempting to connect the dialysate connector to the transfer set.
- the shell of the connector includes teeth that mate with a plurality of ramps disposed on a rib or ring of the transfer set.
- the ramps are alternatively ribs or other shaped protrusions, which provide a different tactile feedback to the patient when the connector and transfer set are mated.
- the shell includes a female undercut that threads over a bump protruding from the ring or rib of the transfer set.
- the dialysate connector or the transfer set is provided with an o-ring or gasket.
- the o-ring or gasket can have one of many different cross-sections and can be sealed axially or radially between the shell of the connector and the transfer set.
- the transfer set is provided with cantilevers or protrusions that increase a friction force as the connector is threaded over the transfer set.
- the shell of the dialysate connector can be provided with one or more arms or snap-fitting extensions that snap-fit onto a portion of the transfer set when the connector and transfer set are mated fully.
- an advantage of the present invention is to provide a dialysis connector that reduces the likelihood of peritonitis.
- Another advantage of the present invention is to provide a dialysis cap that remains attached to a catheter set after use.
- Still another advantage of the present invention is to provide a connector and a cap therefore having a septum that automatically reseals upon removal of the cap from a shell that couples to the dialysate container.
- a further advantage of the present invention is to provide a dialysis connector employing a sealed disinfectant in conjunction with a releasable and resealable cap, which effectively minimizes the spread of microbial contamination to a catheter transfer set, and thus to the patient, during dialysis therapy.
- Yet another advantage of the present invention is to provide a cap for use in PD, including CAPD and APD that contains a disinfectant and that cannot spill the disinfectant when a tip protector is removed.
- Yet a further advantage of the present invention is to provide a cap for use in CAPD and APD that contains a continuous amount of a disinfectant and does not require an absorbent material to hold the disinfectant.
- an advantage of the present invention is to provide a resealable cap enclosed within a protective shell prior to insertion of a catheter set.
- FIG. 1A is a perspective view of one embodiment of the dialysis connector and cap therefore of the present invention.
- FIG. 1B is a schematic sectional view showing an embodiment of an interface between the shell and the tip protector.
- FIG. 1C is a schematic sectional view showing another embodiment of an interface between the shell and the tip protector.
- FIG. 2 is a perspective view illustrating a part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient.
- FIG. 3 is a perspective view illustrating another part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient.
- FIG. 4 is an elevation view illustrating one step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.
- FIG. 5 is an elevation view illustrating another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.
- FIG. 6 is an elevation view illustrating a further step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.
- FIG. 7 is an elevation view illustrating still another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient.
- FIG. 8 is an exploded elevation view illustrating one preferred transfer set end for moving a disinfectant housing seal within the dialysate connector and for providing tactile, visual and/or audio feedback to the patient.
- FIG. 9 is a perspective view of a portion of the transfer set shown in FIG. 8 .
- FIG. 10 is a perspective view of the dialysis connector and transfer set of FIG. 8 when engaged.
- FIG. 11 is an exploded perspective view of an alternative dialysis connector and transfer set having an alternative apparatus for providing audio, visual and/or tactile feedback.
- FIG. 12 is a sectioned elevation view of an assembled dialysate connector and transfer set illustrating a further alternative embodiment for providing audio, visual and/or tactile feedback to the patient.
- FIG. 13 is a sectioned elevation view of an assembled dialysate connector and transfer set illustrating yet a further alternative embodiment for providing audio, visual and/or tactile feedback to the patient.
- FIGS. 14 and 15 are perspective and sectioned elevation views, respectively, illustrating a locking mechanism of the present invention, which locks an assembled dialysate connector and transfer set in place.
- FIGS. 16 and 17 are sectioned elevation views of assembled dialysate connectors and transfer sets illustrating further alternative embodiments for providing assembly retention and feedback to the patients, which include the use of a gasket.
- the present invention provides a connector and a cap therefore that includes a disinfectant for any system requiring a connection, such as a connection of a first length of tubing or other conduit to a second length of tubing or other conduit, such as for PD.
- the present invention provides a safe and easy connection and method for introducing a disinfectant for a user/patient.
- the connector and cap therefore do not create a mess and do not make the user/patient perform special handling in order not to spill the disinfectant contained therein.
- the method and apparatus for the present invention can be used to perform Continuous Ambulatory Peritoneal Dialysis (“CAPD”) and Automated Peritoneal Dialysis (“APD”), collectively referred to herein as Peritoneal Dialysis (“PD”).
- CAPD Continuous Ambulatory Peritoneal Dialysis
- APD Automated Peritoneal Dialysis
- PD Peritoneal Dialysis
- the connector and cap and method for using same can be used in a variety of other applications, particularly applications that insert a medical fluid into the body of a patient.
- FIG. 1A illustrates that the connector 10 includes a cap 12 .
- the components of the present invention including the cap 12 , are made of a plastic material such as polyethylene, polypropylene, nylon, polystyrene, polyester, PVC, a blend of various plastics or any other plastic or synthetic material that is capable of being washed and sterilized or substantially sterilized.
- certain components of the connector 10 seal to other components. These sealing components are generally made from compressible materials such as compressible rubber, e.g., silicone or the like.
- the components of the connector 10 are constructed into desired shapes via any known method for producing plastic or rubber pieces, such as a molding process, e.g., an injection molding process.
- the compressible or rubber pieces may alternatively be cut and/or stamped from a larger piece of the compressible or rubber material.
- one or more of the components, i.e., the plastic components may alternatively be constructed from a metal, e.g., a non-corrosive metal such as stainless steel or aluminum, and may be formed via any known method of forming or stamping same.
- the cap 12 includes a body 14 that is injection molded or blow molded to define a desired shape.
- FIG. 1A shows one embodiment of the connector 10 and the cap 12
- the body 14 of the cap 12 may be made in a variety of different shapes and sizes to mate with and/or work with various systems for introducing medical fluids into a patient.
- the various systems can be provided by other manufacturers or by the assignee of this invention.
- the body 14 defines the following components or features.
- the body 14 defines at least one receptacle 16 .
- the receptacle 16 is a well or other liquid containing shape that encompasses a void except for a sealable side.
- the body 14 can define a variety of different receptacles 16 ; however, FIG. 1A shows an embodiment wherein the body 14 defines a single receptacle 16 .
- a seal 18 encloses or caps off the receptacle 16 .
- the seal 18 in an embodiment is a cross-linked elastomeric seal made from silicone.
- the seal may alternatively be made from any other type of rubber or compressible material such as neoprene, vinyl, viton, buna-n, butyl, EPDM, latex or the like.
- the seal 18 can be made from solid or sponge rubber. In an embodiment, the seal 18 may be clear so that the user or patient can see a disinfectant 20 housed between the seal and the receptacle 16 . In an embodiment, the seal 18 is coated with or impregnated with a disinfectant, which acts to further sterilize the connector 10 .
- the seal 18 compresses against the walls of the receptacle 16 , so that the disinfectant 20 residing within the receptacle 16 in any suitable form and/or manner cannot initially escape, even if the cap 12 of the connector 10 is turned so that the seal 18 faces downward and even if the patient or user moves, manipulates, shakes or otherwise causes the disinfectant 20 to move within the receptacle 16 .
- the seal 18 compressed within the walls of the receptacle 16 , is translatable so that the seal 18 can move towards an end of the receptacle 16 .
- the method for translating the seal 18 is set forth in detail below in connection with FIGS. 3 to 7 .
- the seal 18 is thin or otherwise frangible, e.g., is constructed from a thin plastic or metal-coated plastic sheet. The sheet is designed to rip when the patient or user applies pressure to the sheet, wherein the disinfectant flows through the ruptured sheet of the seal 18 .
- the seal 18 would not compress against the walls of the receptacle 16 ; rather, a suitable adhesive would be used to secure the seal 18 to the receptacle 16 , or the seal 18 could be adhered to the receptacle 16 via a known heat-shrinking or heating process.
- the disinfectant 20 is adaptable to be any suitable type, form and/or amount of disinfectant that can sterilize or substantially sterilize plastic, rubber, metal or other like materials.
- the disinfectant 20 is composed of povidone iodine. It should be appreciated that the povidone iodine can be provided in any suitable form and/or amount thereof In an embodiment, a povidone iodine gel may have been subjected to gamma irradiation, steam sterilization and/or ethylene oxide.
- the disinfectant is or includes iodine-containing antimicrobials.
- the disinfectant uses or includes a povidone iodine (not in gel form) that is or may be subjected to gamma irradiation and/or steam sterilization.
- the disinfectant is or includes betadine. It should be appreciated that the disinfectant 20 of the present invention can alternatively be any desired disinfectant known to those of skill in the art.
- the body 14 of the cap 12 also in an embodiment defines internal threads 22 and external threads 24 .
- the internal threads 22 and external threads 24 reside on the same end of the cap 12 .
- the purpose of the inner and outer threads will be shown below. It is important to note, however, that the relative relationship between the internal threads 22 and the external threads 24 is not important to the operation of the present invention.
- the body 14 of the cap 12 enables the first member to move along the central axis of the body 14 via one of the set of threads.
- the body 14 of the cap 12 also enables a second member to move along the central axis of the body 14 .
- the inner threads 22 and the outer threads 24 may have any thread pitch desired by the implementor of the present invention.
- the external threads 24 are slightly tapered, for example, at about one degree.
- the threads are straight, such as in a lead screw or ball screw.
- the external threads 24 enable one member to translate relative to another, wherein the member eventually bottoms out or has a limited range of travel with respect to the external threads 24 .
- the inner threads 22 may be straight threads that allow a member to rotate freely in and out of the body 14 or the inner threads 22 may be tapered such that the member bottoms out as it inserts into the body 14 .
- the body 14 defines a passage 26 that enables a medical fluid such as a dialysate to move from one end of the cap 12 to another.
- the passage 26 can alternatively be the opening defined by the inner threads 22 and does not have to include the reduced tubing piece illustrated as the passage 26 in FIG. 1A .
- the passage 26 is sized to have approximately the same inner diameter as the tubes or catheters carrying the dialysate back and forth from a dialysate container and the peritoneal cavity of the patient.
- the body 14 defines a housing 28 at an end opposing the internal and external threads 22 , 24 .
- the housing 28 is sized to hold a septum 30 .
- the housing 28 is swaged to the septum 30 or otherwise holds the septum 30 in a snug manner.
- the septum 30 cannot move in either axial direction relative to the body 14 .
- the body 14 defines an end wall 32 having a smaller inner diameter than that of the housing 28 , which also holds the compressible septum 30 in place.
- a suitable adhesive may also be employed to hold the septum 30 within the housing 28 .
- the septum 30 is cylindrical as is the body 14 and the connector 10 in general.
- the septum 30 , the body 14 , and the connector 10 can each have alternative shapes such as being square or rectangular.
- the septum 30 in an embodiment is made of a compressible or rubber material.
- the septum can be made from any type of rubber, including any of the above listed rubbers.
- the septum 30 defines a slit (not illustrated) which enables a tube or other type of fluid communication member to pass through a back wall 34 of the septum 30 .
- the septum 30 in the illustrated embodiment generally defines a cap- or nut-shaped rubber or otherwise compressible piece having the back wall 34 and a cylindrical side wall 35 that extends from the back wall 34 .
- the nut-shaped or cap-shaped septum in an embodiment is made as one piece, wherein the slit is made in the back wall 34 .
- a tube or fluid communication member then inserts and resides inside a hollow chamber defined by the septum 30 and at some point is able to pass through the back wall 34 .
- the connector 10 is configured so that the external threads 24 of the body 14 mate with internal threads of a shell 36 .
- the shell 36 is a plastic or metal piece and may be of the same material as the body 14 of the cap 12 .
- the shell 36 defines the internal threads 38 that mate with the external threads 24 of the body 14 .
- the shell 36 can thus translate in either axial direction relative to the body 14 by rotating in a clockwise or counterclockwise direction about the body 14 .
- the shell 36 defines a tube or port 40 , which in an embodiment is integrally formed with the shell 36 , e.g., through an injection molding or blow molding process.
- the tube 40 extends inwardly into a cavity defined by the shell 36 and into the body 14 of the cap 12 through an opening defined by the end wall 32 of the body 14 .
- the tube 40 also inserts into the cavity defined by the septum 30 .
- an end 41 of the tube 40 abuts or is directly adjacent to the back wall 34 of the septum 30 .
- the tube or port 40 also extends outwardly from the shell 36 .
- the tube or port 40 sealingly connects to a tube (not illustrated) that runs to a dialysate container or a container housing the medical fluid that transfers through the connector 10 of the present invention.
- the tube connecting to the dialysate bag press fits or sealingly fits over the port 40 in such a way that the dialysate does not leak from the interface of the flexible tube running to the dialysate container and the port 40 .
- the tube of the dialysate bag can also connect to the port 40 via a solvent bond.
- the dialysate is generally transferred back and forth, to and from, the dialysate container under its own weight and generally does not require an external pump or pressure system to drive the flow. Therefore, the fluid is not under substantial pressure and the seal required for the port 40 is not difficult to achieve.
- a hose clamp or other type of releasably fastenable device may be used to bolster the seal made between the flexible tube running to the dialysate bag and the port 40 . Such interface is made readily and without requiring the patient or user to have an excessive amount of strength or to perform overly intricate operations.
- a tip protector 42 fits over the shell 36 and at the same time fits into the interior cavity defined by the internal threads 22 of the body 14 .
- the tip protector 42 is made in an embodiment of any of the plastic materials described above.
- the tip protector 42 defines a ring or handle 44 that enables the user or patient to remove the tip protector 42 from the shell 36 to begin using the connector 10 . That is, the connector 10 is initially packaged with the tip protector 42 . The first time the user or patient uses the tip protector 42 , the user or patient removes the tip protector and discards it.
- the tip protector 42 serves a number of purposes in protecting the connector 10 prior to use.
- the tip protector 42 provides a microbial barrier.
- the tip protector 42 disallows bacteria and other harmful airborne agents from entering the body 14 of the cap 12 prior to use.
- the patient or operator removes the tip protector 42 . In this way, the inside of the body 14 of the cap 12 is only exposed to open air for a very short amount of time.
- the tip protector 42 when the connector 10 is to be used for CAPD, the tip protector 42 also sets the shell 36 at the appropriate distance relative to the body 14 for packaging the connector 10 . That is, the tip protector 42 helps to set the end 41 of the tube 40 of the shell 36 directly adjacent to the back wall 34 of the septum 30 .
- the tube 40 does not insert into or open up the slit (not illustrated) in the back wall 34 of the septum 30 .
- FIGS. 1A and 1B illustrate that the tip protector 42 in an embodiment defines threads 46 that engage some of the internal threads 38 of the shell 36 .
- the shell 36 only threads into the tip protector 42 so far before the shell 36 bottoms out against a cylinder 48 defined by the tip protector 42 .
- FIG. 1B illustrates that in an embodiment, the outside of the shell 36 includes a taper 35 at the end of the portion of the shell 36 defining the threads 38 . As the tip protector 42 threads into the shell 36 , the taper 35 increasingly presses against the inside of the cylinder 48 .
- the cylinder 48 of the tip protector 42 defines a stepped portion 47 that facilitates the engagement between the taper 35 of the shell 36 and the tip protector 42 .
- the tip protector 42 can be placed against or abutted against the body 14 of the cap 12 before the shell 36 threads onto the body 14 and onto the threads 46 of the tip protector 42 .
- the shell 36 threads over the external threads 24 of the body 14 and passes or translates past the body 14 a desired distance defined by the threads 46 of the tip protector 42 . It is at this point that the end 41 of the tube 40 abuts or is directly adjacent to the end wall 34 of the septum 30 .
- the cylinder 48 of the tip protector 42 is not threaded and does not threadingly engage the shell 36 so that the cylinder 48 simply slides over and translates relative to the shell 36 . It should also be appreciated that to remove the tip connector 42 , the user holds the shell 36 and rotates the ring 44 a number of turns.
- FIG. 1C illustrates an alternative embodiment that is used, for example, when the connector 10 performs APD.
- the tip protector 42 simply slides and possibly slightly press fits onto or into the body 14 of the cap 12 .
- the tip protector 42 does not define the threads 46 .
- the shell 36 may or may not be tapered and may contain a stepped member 37 , wherein the member 37 is intended to slightly frictionally engage the inner wall of the cylinder 48 .
- the internal threads 38 of the shell 36 stop before reaching the inner portion 39 of the shell 36 that abuts the tip protector 42 .
- the tip protector 42 also includes an inner extension 50 that extends into the chamber created by the internal threads 22 of the body 14 .
- the extension 50 extends so that it abuts or is directly adjacent to the seal 18 . This ensures that prior to use, the seal 18 does not loosen and move away from the receptacle 16 to thereby create a leaky connector 10 .
- the tip connector 42 enables the connector 10 to be handled and shipped without destroying the seal 18 and/or losing the disinfectant 20 maintained by the seal 18 .
- the connector 10 may be adapted to operate with many different types of connectors or devices that provide a catheter 62 that inserts into the peritoneal cavity of the patient.
- the connector 10 is adapted to attach to a transfer set that is illustrated in FIG. 2 as the connector 60 .
- the transfer set in one embodiment is a MiniSetTM manufactured by the BAXTER INTERNATIONAL INC.
- MiniSetTM 60 is one operable embodiment of the transfer set or catheter device, the connector 10 can operate with any type of device that couples to a tube or catheter, which inserts into the patient's peritoneal cavity.
- the tip protector 42 is unsecured or removed from the shell 36 of the connector 10 .
- the port 40 of the shell 36 of the connector 10 is illustrated as sealingly connecting to a flexible tube 64 that runs to the dialysate container or bag.
- FIG. 3 illustrates that after inserting the connector 10 onto the connector or transfer set 60 , the shell 36 connected to the tube 64 threads off of and away from the cap 12 .
- the connector 10 threads onto the connector or transfer set 60 using the internal threads 22 defined by the body 14 of the cap 12 , which are exposed when the tip protector 42 is removed.
- FIG. 3 illustrates a point in the process when the patient has completed the transfer of the dialysate from the dialysate container into the peritoneal cavity. Or, FIG. 3 illustrates a point in the process when the patient or user has finished draining spent dialysate from the peritoneal cavity into the dialysate container.
- the cap 12 of the container 10 remains fixed to the connector or transfer set 60 and thereby caps off the transfer set 60 . In this manner, because the sterility of cap 12 is maintained and cap 12 remains functional, a separate cap which would normally have to be taken off and re-placed onto the transfer set 60 before and after each use is no longer necessary.
- FIG. 4 illustrates a point in the process when the tip protector 42 has been removed and the transfer set or connector 60 is ready to be connected to the connector 10 .
- the connector or transfer set 60 has not engaged the seal 18 to thereby rupture or displace the seal, which displaces the disinfectant 20 .
- the connector or transfer set 60 includes external threads 64 that mates with the internally facing threads 22 of the body 14 of the cap 12 .
- the user or patient When the user or patient desires to connect the catheter from the peritoneal cavity to the connector 10 , the user or patient threads the connector or transfer set 60 (connecting to the catheter extending to the peritoneal cavity) into the body 14 of the cap 12 so that ends 66 of the connector transfer set 60 engage the seal 18 and either move it or rupture it (best seen in FIG. 5 ). That is, the ends 66 apply a translational force to the seal 18 which causes the seal 18 to compress against the disinfectant 20 .
- the seal 18 remains intact but moves or displaces the disinfectant 20 to run out over the outside of the threads 64 of the connector 60 , so that microorganisms contained thereon are substantially destroyed.
- the seal 18 as illustrated may be made in a teardrop-type shape wherein the blunt end of the teardrop has more sealing force than the tapered or sharper end of the seal 18 . In this manner, the sharper or tapered end may slightly deform as the blunt end is dragged along the surface of the receptacle 16 .
- the mating connector 60 in an embodiment is sized to engage and slide along the passage 26 of the body 14 . This also aids in dispersing the disinfectant 20 onto the outside of the mating connector 60 to disinfect the engaging threads. That is, the disinfectant will take the path of least resistance and tend to move into the open cavity defined between the outside of the connector 60 and an inner wall of the body 14 , rather than squeezing through the friction fit between the inner opening of the connector 60 and the passage 26 .
- the shell 36 thereby translates towards the mating connector 60 , so that the tube or port 40 of the shell 36 pierces through the back wall 34 of the septum 30 and through the slit defined by the back wall 34 .
- fluid communication exists between the peritoneal cavity of the patient and the dialysate bag.
- the dialysate fluid may flow in either direction. That is, if the patient is removing spent dialysate from the peritoneal cavity, the dialysate fluid can flow from the catheter in the cavity into the mating connector 60 , through the passage 26 of the body 14 , out the port 40 and into the flexible tube 64 running to the dialysate container or bag.
- the user or patient In CAPD, to remove the spent dialysate from the peritoneal cavity, the user or patient typically opens a clamp on the upstream side of the mating connector 60 or integrally formed with the mating connector 60 , wherein the spent dialysate runs into an awaiting container.
- the flex tube 64 typically runs to a “Y” connection, wherein one leg extends to the spent dialysate container and another leg extends to a new dialysate bag.
- the operator opens a fill-bag clamp that enables the new dialysate to run from the flexible tube 64 , to the port 40 , through the septum 30 , through the passage 26 , into the internal diameter of the mating connector 60 and into the catheter leading into the peritoneal cavity.
- APD With APD, one or more pumps automatically pull the spent dialysate from the patient's peritoneal cavity and places fresh dialysate into same.
- FIGS. 4, 5 and 6 illustrate one complete cycle of flushing old or spent dialysate and replenishing new dialysate into the peritoneal cavity. With both CAPD and APD, the cycle is repeated a number of times. Obviously, many other different types of medical fluids may be substituted for the dialysate described herein, wherein a number of medical procedures may be performed using the connector 10 having the cap 12 of the present invention.
- the user or patient removes the shell 36 from the cap 12 , so that the tube 40 of the shell 36 is removed from the septum 30 .
- the slit in the wall 34 of the septum 30 closes and the end of the body 14 is once again sealed.
- the body 14 remains in the threaded position with respect to the mating connector 60 , so that the disinfectant 20 is maintained between the mating threads and the open area between the mating connector 60 and the body 14 .
- End 70 is contoured to include projections or protruding portions 72 and 74 .
- Protruding portions 72 and 74 focus the force applied by transfer set 60 a to seal 18 when dialysate connector 10 a and transfer set 60 a are mated.
- Protruding portions 72 and 74 reduce the amount of operating torque needed to screw dialysate connector 10 a and transfer set 60 a together to move seal 18 completely and dispense all or substantially of the disinfectant residing previously within receptacle 16 located within dialysate connector 10 a.
- Seal 18 needs to move and/or rupture for the disinfectant to be released from within receptacle 16 . Seal 18 also needs to survive relatively extreme conditions to which dialysate connector 10 a is subjected. For example, dialysate connector 10 a may be steam sterilized. Seal 18 must withstand such sterilization or potentially a different type of sterilization. Seal 18 should not be so robust however that a patient with reduced strength and/or dexterity cannot move seal 18 with relative ease.
- Improving the force transfer from end 70 of transfer set 60 a to seal 18 helps to strike a workable and proper balance. That is, protruding portions 72 and 74 aid the patient in the moving or disrupting seal 18 , which allows for easier displacement of the disinfecting gel located within receptacle 16 . At the same time, the torque required to assemble connector 10 a to transfer set 60 a is also reduced.
- the non-uniform contour of end 70 of male threaded portion 68 of transfer set 60 a also tends to prevent seal 18 from adhering to end 70 .
- the adhering or sticking of seal 18 to the end of the transfer set 60 a is more likely to occur if the end of portion 68 is flat.
- a flat end is prone to forming one or more negative pressure pocket between the end and seal 18 when forced against seal 18 .
- Protruding portions 72 and 74 of end 70 prevent or substantially prevent such pockets from forming.
- contoured end 70 including projecting portions 72 and 74 reduces adhesion between the seal 18 and end 70 by (i) reducing the pressure generated by end 70 on seal 18 and by (ii) reducing a surface tension between seal 18 and end 70 .
- Protruding portions 72 and 74 are molded readily onto or into male threaded portion 68 of transfer set 60 a . While two projecting portions 72 and 74 are illustrated, end 70 may have any suitable number of such portions. In the illustrated embodiment, projecting portions 72 and 74 are generally sinusoidal in shape. In alternative embodiments, projecting portions 72 and 74 of end 70 are shaped differently to have a desired form.
- Shell 36 of dialysate connector 10 a includes a head 52 .
- Head 52 defines or includes a plurality of teeth 54 as seen in FIGS. 8 and 10 .
- Teeth 54 extend at least substantially longitudinally from head 52 . That is, teeth 54 extend in a direction that is at least substantially parallel to a centerline or line of connection between the dialysate connector 10 a and transfer set 60 a.
- FIG. 9 illustrates that transfer set 60 a includes a ring portion 76 .
- male threaded portion 68 of transfer set 60 a is removed from transfer set piece 90 to reveal ring 76 .
- a rib 78 projects from ring 76 .
- One or more ramps or projections 80 projects from rib 78 .
- a plurality of ramps 80 are distributed intermittently about the circumference of rib 78 .
- Ramp 80 includes an insertion face 82 and a removal face 84 .
- FIG. 10 illustrates head 52 of shell 36 threaded onto ring 76 of transfer set 60 a .
- fingers 54 contact and abut rib 78 .
- Rib 78 provides a slight interference fit between transfer set 60 a and fingers 54 of head 52 of dialysate connector 10 a. The slight interference fit helps to prevent dialysate connector 10 a from coming loose from transfer set 60 a during treatment.
- Rib 78 also provides tactile feedback to the patient to signal that the connection between dialysate connector 10 a and transfer set 60 a is nearing completion.
- Ramps 80 provide a retention benefit as well as feedback to the patient.
- a leading edge of teeth 54 engages the ramp insertion face 82 of ramp 80 radially.
- the angle of ramp insertion face 82 provides an increasing amount of tactile feel to the patient.
- the tooth 54 slides completely over face 82 of ramp 80 and snaps downward along face 84 and against rib 78 .
- the following edge of tooth 54 is locked against ramp removal face 84 of ramp 80 .
- the snapping of tooth 54 provides further tactile and potentially audible feedback to the patient. The patient can also visually see that the tooth 54 has moved over ramp 80 .
- transfer set 60 a in one embodiment includes a plurality of ramps 80 and that multiple teeth 54 can make tactile and retention contact with multiple ramps 80 simultaneously, substantially simultaneously or at different times as the connector 10 a and transfer 60 a are threaded together. Furthermore, multiple teeth 54 will pass over the same ramp 80 , providing feedback over a period of time.
- Transfer set 60 a also includes a stop or shoulder 86 .
- Stop or shoulder 86 prevents connector 10 a from being over-tightened to transfer set 60 a .
- Ring 76 , rib 78 , stop or shoulder 86 and the internal threads illustrated in FIG. 9 can all be made as part of a single integral piece 90 .
- Piece 90 in one embodiment is metallic.
- piece 90 of transfer set 60 a is made of a polymer or plastic.
- the patient When the patient is using a CAPD or APD system and is ready to connect dialysate connector 10 a to the transfer set 60 a , the patient first removes a tip protector, such as tip protector 42 shown in FIGS. 1A to 1 C and FIG. 2 from the dialysate connector. Tip protector 42 is removed from the shell 36 of connector 10 a . Removing such tip protector exposes the head 52 and teeth 54 of shell 36 of dialysate connector 10 a.
- a tip protector such as tip protector 42 shown in FIGS. 1A to 1 C and FIG. 2
- FIG. 3 shows cap 12 connected to transfer set 60 .
- a dialysate connector 10 initially houses cap 12 . Once shell 36 is pulled away from a transfer set 60 , cap 12 remains on the transfer set. To insert a new dialysate connector 10 , the previously used cap 12 is removed.
- the transfer set 60 (referring collectively to set 60 a , etc.) is then inserted into the dialysate connector 10 (referring collectively to set 10 a , etc.).
- clicks are heard, felt and seen when teeth 54 engage and snap over the protrusions or ramps 80 located on the rib portion 78 of ring 76 .
- ramp removal face 84 is also angled although at a different angle than ramp insertion face 82 .
- the teeth 54 are rotated counterclockwise over the differently angled, e.g., more steep ramp face 84 .
- the pitches or angles of the faces 82 and 84 of projections 80 result in a desirable insertion and removal torque, e.g., for patients having poor dexterity and low strength.
- projections or ramps 80 may be located in any frequency about rib 78 of piece 90 . There may be one projection 80 for every several teeth 54 , one projection 80 for every couple of teeth 54 or one projection for each tooth 54 , for example. In an embodiment, projections 80 are provided in a sufficient frequency to produce a ratchet-type connection, in which the patient feels and/or hears multiple clicks as the two pieces are threaded together. In an embodiment, the ramp projections 80 are provided back to back or virtually back to back so that in essence, rib 78 becomes a ring of ramped projections 80 . Alternatively, rib 78 is not provided. Instead, a series of projections 80 extends directly from the diameter of ring 76 .
- Projections 80 may have any suitable shape and are not limited to the ramp faces 82 and 84 shown in FIG. 9 .
- Projections 80 may for example be gear-shaped, generally rectangular, generally triangular, have one or more curved edges and/or one more angled edges. The angles and/or curves are chosen to provide a desired amount of resistance that balances the need for a retention force and tactile feedback with the fact that persons with limited strength may be assembling connector 10 a to the transfer set 60 a.
- a ramped shaped projection is provided, however, the ramp projects longitudinally upward from ring 76 towards stop 86 instead of radially up and down as shown in FIG. 9 .
- shell 36 provides inwardly facing teeth and ring 76 or rib 78 defines indents or detents that mate with such inwardly facing teeth.
- Dialysate connector 10 b includes a head 52 , like connector 10 a of FIGS. 8 to 10 .
- head 52 includes or defines a plurality of outwardly extending ratchet-like projections 56 . Projections 56 are provided in lieu of the longitudinally extending teeth 54 of connector 10 a in FIGS. 8 to 10 .
- Transfer set 60 b includes a piece 90 having a ring portion 76 .
- Ring portion 76 includes or defines a plurality of inwardly facing ratchet-like projections or teeth 88 .
- Inwardly facing projections 88 mate with outwardly extending projections 56 in a ratchet-like manner to provide tactile feedback to the user or patient, e.g., to let the patient know that a connection between connector 10 b and transfer set 60 b is almost or totally complete.
- the ratchet-like connection also provides a retention force to help hold the connector 10 b and transfer set 60 b together when mated.
- dialysate connector 10 b may include inwardly facing ratchet-like teeth, while the transfer set 60 b includes or defines outwardly facing ratchet-like teeth.
- the ratchet-like teeth may be generally triangular in cross-section or have any suitable cross-sectional shape.
- dialysate connector 10 c and transfer set 60 c a further alternative embodiment of the present invention is illustrated by dialysate connector 10 c and transfer set 60 c .
- Shell 36 of transfer set 10 c includes a plurality of inwardly facing projections 58 a to 58 c .
- Projections 58 a to 58 c may or may not be part of a thread that threads onto mating threads of transfer set 60 c.
- projection 58 c extends inwardly and annularly within shell 36 of connector 10 c .
- Projection 58 c is oriented in an embodiment in a plane that is substantially perpendicular to a center of axis 92 extending through transfer set 60 c and shell 36 . That orientation enables an undercut 94 formed in projection 58 c to ride along a projection 96 extending outwardly from piece 90 of transfer set 60 c .
- Undercut 94 includes a female contour that at least substantially matches a male contour of outwardly extending projection 96 .
- shell 36 of connector 10 c threads onto transfer set 60 c until undercut 94 of projection 58 c mates with outwardly extending projection 96 of piece 90 of transfer set 60 c .
- Piece 90 of transfer set 60 c also includes a hardstop 98 that precludes shell 36 from being over-tightened, in which case undercut 94 could spin off of outwardly extending projection 96 .
- the interface between undercut 94 and projection 96 provides tactile feedback to the patient or user. Additionally, the mated pieces help to hold shell 36 in place with respect to transfer set 60 c when fully mated onto the transfer set.
- dialysate connector 10 d and transfer set 60 d a further alternative embodiment of the present invention is illustrated by dialysate connector 10 d and transfer set 60 d .
- shell 36 includes a plurality of arms 102 and 104 . Arms 102 and 104 are set apart from shell 36 via standoffs 106 . Standoffs 106 provide pivot points upon which arms 102 and 104 can flex. As seen in FIG. 13 , arms 102 and 104 in an embodiment are bowed slightly outwardly. The patient or user presses arms 102 and 104 at the proximal side of standoffs 106 . Such action causes the distal ends 108 of arms 102 and 104 to spread outwardly according to the arrows shown, so that shell 36 and connector 10 d can be unthreaded from transfer set 60 d.
- the snap-fitting of arms 102 and 104 onto transfer set 60 d provides audio, visual and tactile feedback to the user that a connection is complete.
- the snap-fitted arms and associated projection or indentation also provide a retention function, holding shell 36 on the transfer set 60 d until the patient presses the arms and twists shell 36 off of the transfer set.
- Dialysate connector 10 d provides a further advantage.
- Arms 102 and 104 can also be sized to hold tip protector 42 in place so that it cannot inadvertently come loose from the open edge of connector 10 d.
- the arms can be configured to snap-fit over the cylinder 48 of tip protector 42 to hold tip protector 42 in place.
- the patient presses arms 102 and 104 to release distal ends 108 of the arms from cylinder 48 of tip protector 42 . The patient removes tip protector 42 from the connector with the patient's other hand.
- FIG. 14 illustrates that snap-holding collar 110 includes a first portion 112 that snap-fits over the head 52 of shell 36 .
- a second portion 114 of collar 110 snap-fits over the ring portion 76 of transfer set 60 .
- Snap-holding clip 110 holds the connector 10 and transfer set 60 together after they have been mated so that the two cannot come apart during therapy.
- collar 110 is a piece formed separately from connector 10 and transfer set 60 .
- clip or collar 110 is fixed permanently to transfer set 60 .
- the collar 110 would slide left to right to snap-fit over a projection or indentation 116 defined by shell 36 .
- the sliding collar 110 is flexible enough to be pulled away from shell 36 when the shell needs to be removed from transfer set 60 .
- the indentation of projection 116 can be made small enough and/or first portion 12 can be made pliable enough so that removing collar 110 in a sliding manner is not overly difficult.
- collar 110 provides feedback to the patient that the connector 10 and transfer set 60 are fully mated. That is, collar 110 will not fit properly if connector 10 and transfer set 60 are not mated properly. Also, collar 110 helps to hold connector 10 and transfer set 60 together after they are fully mated. In this capacity collar 110 serves a retention function.
- FIGS. 16 and 17 other embodiments of the present invention are illustrated. Both embodiments of FIGS. 16 and 17 employ a gasket. Also, both embodiments employ dialysate connector 10 , such as connector 10 shown in FIGS. 1A and 2 to 7 .
- the connector of FIG. 16 provides a gasket 120 that is compressed inwardly about ring portion 76 of transfer set 60 e .
- shell 36 in FIG. 17 compresses gasket 122 longitudinally against a stop 124 extending radially from ring portion 76 of transfer set 60 f.
- gasket 120 is housed within an annular groove 126 defined in ring portion 76 of transfer set 60 e .
- gasket 120 in an embodiment is an o-ring type gasket.
- gasket 120 is flat in cross-section or has any suitable cross-sectional shape.
- Gasket 122 in FIG. 17 is housed within a shallow well defined by stop 124 .
- gasket 122 has a flat washer-type shape.
- gasket 122 has any suitable o-ring or cross-sectional shape.
- Gaskets 120 and 122 provide retention resistance that helps to secure shell 36 onto transfer sets 60 e and 60 f , respectively. Moreover, gaskets 120 and 122 provide at least tactile and visual feedback to the patient to inform same that the assembly is at least substantially complete.
Abstract
Description
- This application is a continuation-in-part application of U.S. Non-Provisional Patent Application No. 10/074,532, filed Feb. 11, 2002, entitled “Dialysis Connector And Cap Having An Integral Disinfectant”, the entire contents of which are hereby incorporated by reference and relied upon.
- The present invention relates generally to medical treatments. More specifically, the present invention relates to medical connectors for use in medical treatments, such as Peritoneal Dialysis (“PD”).
- Due to disease, insult or other causes, a person's renal system can fail. In renal failure of any cause, there are several physiological derangements. The balance of water, minerals and the excretion of daily metabolic load is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.
- Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body that would otherwise have been removed by normal functioning kidneys. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is life saving. One who has failed kidneys could not continue to live without replacing at least the filtration functions of the kidneys.
- PD uses a dialysis solution or dialysate, which is infused into a patient's peritoneal cavity. The dialysate contacts the patient's peritoneal membrane in the peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the bloodstream into the dialysate occurs by diffusion and osmosis because there is an osmotic gradient across the peritoneal membrane. The spent dialysate is drained from the patient's peritoneal cavity to remove the waste, toxins and water from the patient. New dialysate replaces the spent dialysate and the process repeats.
- During dialysis therapy, a dialysis fluid exchange generally includes draining spent dialysis fluid from the peritoneal cavity and filling the peritoneal cavity with fresh dialysate. Keeping track of the amounts or volumes of dialysis solution drained from and supplied to the peritoneal cavity is important for proper dialysis therapy. A typical amount of dialysate solution drained from and supplied to the peritoneal cavity of an adult during an exchange can be roughly two to three liters. Dialysis fluid exchanges have been performed manually, usually by the patient, or automatically, by an automated dialysis machine.
- In the manual PD technique, known as Continuous Ambulatory Peritoneal Dialysis (“CAPD”), a catheter is implanted into the peritoneal cavity of the patient. A dialysis solution (“dialysate”) is introduced through the catheter into the peritoneal cavity of a patient. Typically, a container of the dialysate connects to a connector, which in turn couples to the catheter. To start the flow of dialysate into the peritoneal cavity, a clamp on a tube connecting the container to the connector is loosened or a valve is opened. In many cases the container is located vertically above the patient and gravity fed into the peritoneal cavity.
- In the Automated Peritoneal Dialysis technique (“APD”), dialysis machines use one or more fluid pumps to perform the dialysate exchanges. The pump pumps spent dialysate fluid out of the peritoneal cavity during the drain mode and pumps dialysate into the cavity during the fill mode.
- In either PD technique, once the dialysate reaches the patient, dialysis of urea, toxic waste and the like takes place between the dialysate and the blood passing through blood vessels in the peritoneum, which is the lining of the peritoneal cavity. The dialysate remains in the peritoneal cavity for several hours. Thereafter, the dialysate is removed from the peritoneal cavity carrying with it diffused breakdown products from the blood. In CAPD, one method for removing the spent dialysate is to lower the dialysate container outside of the body and let the dialysate drain into the container.
- The spent container is disconnected and discarded, wherein a new container of dialysate fluid is attached and the process is repeated. This process may be repeated several times or continuously repeated. Because many patients perform the PD (CAPD or APD) procedure themselves, it is important that the connector which connects the dialysate container to the catheter is easy to use and provides a secure connection.
- A frequent problem that occurs with PD is peritoneal infection or peritonitis which can readily occur given the repeated disconnecting and reattaching of the dialysate containers. Peritonitis results if connections are made between the peritoneal catheter and the connector communicating with the dialysis container in a manner that permits even a very small number of microorganisms to enter the catheter. The microorganisms will be flushed into the peritoneal cavity. Peritonitis can occur even when extreme caution is observed in making and unmaking the connections. Peritonitis can be painful and can temporarily diminish the hydraulic permeability of the peritoneal membrane, rendering the renal treatment less successful.
- Methods to prevent peritonitis have included thoroughly cleansing the connector and the tube connecting the dialysate container before the connection is made. For instance, the connector can be immersed in povidone iodine, betadine or other type of disinfectant. These methods however are messy, time consuming, effort consuming, inconsistent and may be subject to overkill in order to achieve consistently effective results. Hospital workers, as another precaution, typically wear sterile rubber gloves to prevent or guard against any possible peritoneal invasion of bacteria. However, the spread of contamination can still occur due to, for example, a cut in the glove or other like condition.
- Accordingly, the frequent connections that must be made and broken between the catheter residing in the peritoneal cavity and a succession of dialysate containers has created a need to ensure the sterilization of connectors used in performing CAPD and APD. The connections need to be substantial enough to not loosen or become disconnected during dialysis. Patients with poor physical strength and manual dexterity however need to be able to engage and disengage the connectors with relative ease.
- A continuing need therefore exists to provide a simple and effective method and apparatus for performing PD, including CAPD and APD both in hospitals and at a patient's home.
- The present invention relates to a connector and a cap that are easily and readily attachable to a dialysate container and a catheter inserted into a patient's peritoneal cavity. The connector and the cap enable the dialysate to be readily transported between the container and the peritoneal cavity while minimizing the potential of contamination therein due to, for example, handling during use.
- To this end, in an embodiment of the present invention, a connector includes a shell that encloses a cap. The cap houses a slit septum. The cap also includes a sealed disinfectant within an interior receptacle. The seal in an embodiment is a cross-linked elastomeric seal, e.g., a silicone seal. In one embodiment, the disinfectant includes a povidone iodine or PVP-I. The connector is also initially packaged including a tip protector that encloses the shell/cap assembly and provides a barrier to microbial contamination prior to use.
- In another embodiment of the present invention, a cap for use in a connector making a resealable fluid path is provided. The cap includes a body that defines a fluid flow passage and a disinfectant receptacle. The receptacle houses the disinfectant. A seal is disposed within the body. The seal seals the disinfectant between the seal and the receptacle.
- In an embodiment, the body defines an opening that receives a fluid communication member. The fluid communication member is capable of displacing the seal when the body receives the member.
- In an embodiment, the disinfectant disperses between an outer wall of the fluid communication member and an inner wall of the body when the seal is displaced.
- In an embodiment, the body defines outer threads.
- In an embodiment, the outer threads engage mating threads of a shell and enable the shell to translate with respect to the body. The translating shell causes a sealed end of the body to be pierced.
- In an embodiment, the body defines inner threads.
- In an embodiment, the inner threads engage mating threads of a fluid communication member and enable the member to translate with respect to the body. The translating member causes the seal to be displaced.
- In an embodiment, the seal is moveable.
- In an embodiment, the body includes a tube portion that defines the fluid flow passage. The disinfectant receptacle resides about the tube portion.
- In an embodiment, a portion of the passage is sized to house a member that deforms to seal about a tube.
- In an embodiment, the member automatically closes when the tube is removed from the member.
- In still another embodiment of the present invention, a connector for making a resealable fluid path is provided. The connector includes a cap that defines a fluid flow passage. The cap seals an amount of disinfectant, such as a continuous quantity thereof. A shell moveably engages the cap. The shell includes a fluid communication member. The fluid communication member is capable of piercing a sealed end of the cap and fluidly communicating with the fluid flow passage when the shell moves with respect to the cap.
- In an embodiment, the disinfectant includes povidone iodine.
- In an embodiment, the connector includes a tip protector that engages the shell.
- In an embodiment, the shell attaches to a fluid line running to a dialysate container and the cap attaches to a fluid line running to a patient.
- In an embodiment, the sealed end of the cap includes a slit septum.
- In an embodiment, the connector includes an elastomeric seal that seals the disinfectant about the fluid flow passage.
- In still another embodiment of the present invention, a method for providing a sterile connection of a dialysate line is provided. The method includes providing a cap that has a passage and maintains a seal that houses a disinfectant. A first member connects to a first end of the cap. The first member then fluidly communicates with a first dialysate line. A second member connects to a second end of the cap so as to displace the seal and the disinfectant. The second member then fluidly communicates with a second dialysate line.
- In an embodiment, connecting the first member includes moving the first member so as to pierce a sealed end of the cap, which places the first member in fluid communication with the second member.
- In an embodiment, the sealed end of the cap seals about the first member when the first member pierces the sealed end.
- In an embodiment, the sealed end of the cap reseals when the first member is removed from the cap.
- In an embodiment, rupturing the seal includes threading the second member into the cap and exerting pressure on the seal.
- In an embodiment, connecting the second member includes displacing the disinfectant between the cap and the second member.
- In an embodiment, the method further includes maintaining the disinfectant between the cap and the second member after the seal is displaced.
- In an embodiment, the method includes removing the first member from the cap such that the sterile connection between the cap and the second member is maintained.
- In an embodiment, the method includes removing a tip protector and connecting the second member in place of the tip protector.
- In still another embodiment of the present invention, a method for providing PD is provided. The method includes the steps of providing a first member in fluid communication with a dialysate container, a second member in fluid communication with a peritoneal cavity of a patient, and a cap that has a sealed first end, a second end, a passage and maintains a seal that houses a disinfectant; connecting the first member to the sealed first end of the cap; connecting the second member to the second end of the cap so as to displace the seal and the disinfectant thereby causing the first member to pierce the sealed first end of the cap; filling the peritoneal cavity with an amount of fresh dialysate fluid; and removing the first member to automatically reseal the first end of the cap.
- In an embodiment, the method includes removing an amount of spent dialysate fluid from the peritoneal cavity prior to filling the peritoneal cavity with the fresh dialysate fluid.
- In an embodiment, the method includes connecting another first member to the first end, removing spent dialysate fluid from the peritoneal cavity and refilling the peritoneal cavity with fresh dialysate fluid.
- In different embodiments, the filling and removing steps are performed manually or automatically.
- In any of the different embodiments described above, the end of the transfer set or member that moves the seal to displace the disinfectant is contoured to break or move the seal readily so that the seal may be provided and maintained without too much difficulty. The seal is configured to retain the disinfectant under extreme conditions of steam or other type of sterilization technique, but which will also rupture easily to displace disinfectant when needed. In one embodiment, the transfer set end or member that moves or ruptures the seal is contoured so that the force necessary to move the seal fully to displace the disinfectant fully is reduced. Also, the tendency of the seal to adhere to the end of the transfer set or member is lessened.
- In any of the different embodiments described above, a shell of the dialysis connector (e.g., leading from the dialysis supply) and a portion of the transfer set (leading from the patient) can have mating retention and tactile feedback features. Such features help to ensure that the connector and transfer set are tightened enough but not overly tightened. The features can also provide audio, visual and/or tactile feedback to the patient so that the patient knows when it is safe to stop attempting to connect the dialysate connector to the transfer set.
- In one embodiment, the shell of the connector includes teeth that mate with a plurality of ramps disposed on a rib or ring of the transfer set. The ramps are alternatively ribs or other shaped protrusions, which provide a different tactile feedback to the patient when the connector and transfer set are mated. There may be relatively few ramps or the transfer set may include a relatively large number of ramps or protrusions that are spaced apart closely enough from each other to form a ratchet-like fit between the dialysate connector and the patient's transfer set. In another embodiment, the shell includes a female undercut that threads over a bump protruding from the ring or rib of the transfer set.
- In a further alternative embodiment, the dialysate connector or the transfer set is provided with an o-ring or gasket. The o-ring or gasket can have one of many different cross-sections and can be sealed axially or radially between the shell of the connector and the transfer set. Alternatively, the transfer set is provided with cantilevers or protrusions that increase a friction force as the connector is threaded over the transfer set. Still further, the shell of the dialysate connector can be provided with one or more arms or snap-fitting extensions that snap-fit onto a portion of the transfer set when the connector and transfer set are mated fully.
- It is therefore an advantage of the present invention to provide a dialysis connector that eliminates the need for the use and therefore handling of an additional cap to seal a catheter subsequent to use.
- Moreover, an advantage of the present invention is to provide a dialysis connector that reduces the likelihood of peritonitis.
- Another advantage of the present invention is to provide a dialysis cap that remains attached to a catheter set after use.
- Still another advantage of the present invention is to provide a connector and a cap therefore having a septum that automatically reseals upon removal of the cap from a shell that couples to the dialysate container.
- A further advantage of the present invention is to provide a dialysis connector employing a sealed disinfectant in conjunction with a releasable and resealable cap, which effectively minimizes the spread of microbial contamination to a catheter transfer set, and thus to the patient, during dialysis therapy.
- Yet another advantage of the present invention is to provide a cap for use in PD, including CAPD and APD that contains a disinfectant and that cannot spill the disinfectant when a tip protector is removed.
- Yet a further advantage of the present invention is to provide a cap for use in CAPD and APD that contains a continuous amount of a disinfectant and does not require an absorbent material to hold the disinfectant.
- Still further, an advantage of the present invention is to provide a resealable cap enclosed within a protective shell prior to insertion of a catheter set.
- Further still, it is an advantage of the present invention to provide a dialysis connector and patient transfer set that when matted fully provide visual, audio and/or tactile feedback to the patient.
- It is yet a further advantage of the present invention to provide a disinfectant seal and moveable member interface that reduces an amount of force that the member needs to provide to move the seal fully and reduces a likelihood that the seal will adhere to the moved member.
- Additionally, it is an advantage of the present invention to provide a resealable cap having a sealed disinfectant that displaces across threads of the cap and the transfer set.
- Additional features and advantages of the present invention are described in, and will be apparent from, the following Detailed Description of the Invention and the Figures.
-
FIG. 1A is a perspective view of one embodiment of the dialysis connector and cap therefore of the present invention. -
FIG. 1B is a schematic sectional view showing an embodiment of an interface between the shell and the tip protector. -
FIG. 1C is a schematic sectional view showing another embodiment of an interface between the shell and the tip protector. -
FIG. 2 is a perspective view illustrating a part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient. -
FIG. 3 is a perspective view illustrating another part of the process for connecting the connector and cap of the present invention to a transfer set, which connects a catheter to a patient. -
FIG. 4 is an elevation view illustrating one step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient. -
FIG. 5 is an elevation view illustrating another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient. -
FIG. 6 is an elevation view illustrating a further step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient. -
FIG. 7 is an elevation view illustrating still another step for using the connector and cap of the present invention to insert and/or remove a medical fluid into/from a patient. -
FIG. 8 is an exploded elevation view illustrating one preferred transfer set end for moving a disinfectant housing seal within the dialysate connector and for providing tactile, visual and/or audio feedback to the patient. -
FIG. 9 is a perspective view of a portion of the transfer set shown inFIG. 8 . -
FIG. 10 is a perspective view of the dialysis connector and transfer set ofFIG. 8 when engaged. -
FIG. 11 is an exploded perspective view of an alternative dialysis connector and transfer set having an alternative apparatus for providing audio, visual and/or tactile feedback. -
FIG. 12 is a sectioned elevation view of an assembled dialysate connector and transfer set illustrating a further alternative embodiment for providing audio, visual and/or tactile feedback to the patient. -
FIG. 13 is a sectioned elevation view of an assembled dialysate connector and transfer set illustrating yet a further alternative embodiment for providing audio, visual and/or tactile feedback to the patient. -
FIGS. 14 and 15 are perspective and sectioned elevation views, respectively, illustrating a locking mechanism of the present invention, which locks an assembled dialysate connector and transfer set in place. -
FIGS. 16 and 17 are sectioned elevation views of assembled dialysate connectors and transfer sets illustrating further alternative embodiments for providing assembly retention and feedback to the patients, which include the use of a gasket. - The present invention provides a connector and a cap therefore that includes a disinfectant for any system requiring a connection, such as a connection of a first length of tubing or other conduit to a second length of tubing or other conduit, such as for PD. The present invention provides a safe and easy connection and method for introducing a disinfectant for a user/patient. The connector and cap therefore do not create a mess and do not make the user/patient perform special handling in order not to spill the disinfectant contained therein.
- The method and apparatus for the present invention can be used to perform Continuous Ambulatory Peritoneal Dialysis (“CAPD”) and Automated Peritoneal Dialysis (“APD”), collectively referred to herein as Peritoneal Dialysis (“PD”). It should be appreciated, however, that the connector and cap and method for using same can be used in a variety of other applications, particularly applications that insert a medical fluid into the body of a patient.
- Referring now to the figures, and in particular to
FIGS. 1A to 1C, aconnector 10 of the present invention is illustrated.FIG. 1A illustrates that theconnector 10 includes acap 12. Generally, the components of the present invention, including thecap 12, are made of a plastic material such as polyethylene, polypropylene, nylon, polystyrene, polyester, PVC, a blend of various plastics or any other plastic or synthetic material that is capable of being washed and sterilized or substantially sterilized. As is illustrated below, certain components of theconnector 10 seal to other components. These sealing components are generally made from compressible materials such as compressible rubber, e.g., silicone or the like. - The components of the
connector 10 are constructed into desired shapes via any known method for producing plastic or rubber pieces, such as a molding process, e.g., an injection molding process. The compressible or rubber pieces may alternatively be cut and/or stamped from a larger piece of the compressible or rubber material. In alternative embodiments, one or more of the components, i.e., the plastic components, may alternatively be constructed from a metal, e.g., a non-corrosive metal such as stainless steel or aluminum, and may be formed via any known method of forming or stamping same. - The
cap 12 includes abody 14 that is injection molded or blow molded to define a desired shape. AlthoughFIG. 1A shows one embodiment of theconnector 10 and thecap 12, thebody 14 of thecap 12 may be made in a variety of different shapes and sizes to mate with and/or work with various systems for introducing medical fluids into a patient. The various systems can be provided by other manufacturers or by the assignee of this invention. In one embodiment, thebody 14 defines the following components or features. - The
body 14 defines at least onereceptacle 16. Thereceptacle 16 is a well or other liquid containing shape that encompasses a void except for a sealable side. Thebody 14 can define a variety ofdifferent receptacles 16; however,FIG. 1A shows an embodiment wherein thebody 14 defines asingle receptacle 16. Aseal 18 encloses or caps off thereceptacle 16. Theseal 18 in an embodiment is a cross-linked elastomeric seal made from silicone. The seal may alternatively be made from any other type of rubber or compressible material such as neoprene, vinyl, viton, buna-n, butyl, EPDM, latex or the like. - The
seal 18 can be made from solid or sponge rubber. In an embodiment, theseal 18 may be clear so that the user or patient can see adisinfectant 20 housed between the seal and thereceptacle 16. In an embodiment, theseal 18 is coated with or impregnated with a disinfectant, which acts to further sterilize theconnector 10. - In an embodiment, the
seal 18 compresses against the walls of thereceptacle 16, so that thedisinfectant 20 residing within thereceptacle 16 in any suitable form and/or manner cannot initially escape, even if thecap 12 of theconnector 10 is turned so that theseal 18 faces downward and even if the patient or user moves, manipulates, shakes or otherwise causes thedisinfectant 20 to move within thereceptacle 16. - In an embodiment, the
seal 18, compressed within the walls of thereceptacle 16, is translatable so that theseal 18 can move towards an end of thereceptacle 16. The method for translating theseal 18 is set forth in detail below in connection with FIGS. 3 to 7. In an alternative embodiment, theseal 18 is thin or otherwise frangible, e.g., is constructed from a thin plastic or metal-coated plastic sheet. The sheet is designed to rip when the patient or user applies pressure to the sheet, wherein the disinfectant flows through the ruptured sheet of theseal 18. In the alternative embodiment, theseal 18 would not compress against the walls of thereceptacle 16; rather, a suitable adhesive would be used to secure theseal 18 to thereceptacle 16, or theseal 18 could be adhered to thereceptacle 16 via a known heat-shrinking or heating process. - The
disinfectant 20 is adaptable to be any suitable type, form and/or amount of disinfectant that can sterilize or substantially sterilize plastic, rubber, metal or other like materials. In an embodiment, thedisinfectant 20 is composed of povidone iodine. It should be appreciated that the povidone iodine can be provided in any suitable form and/or amount thereof In an embodiment, a povidone iodine gel may have been subjected to gamma irradiation, steam sterilization and/or ethylene oxide. - In another embodiment, the disinfectant is or includes iodine-containing antimicrobials. In a further embodiment, the disinfectant uses or includes a povidone iodine (not in gel form) that is or may be subjected to gamma irradiation and/or steam sterilization. In still another embodiment, the disinfectant is or includes betadine. It should be appreciated that the
disinfectant 20 of the present invention can alternatively be any desired disinfectant known to those of skill in the art. - The
body 14 of thecap 12 also in an embodiment definesinternal threads 22 andexternal threads 24. In the illustrated embodiment, theinternal threads 22 andexternal threads 24 reside on the same end of thecap 12. The purpose of the inner and outer threads will be shown below. It is important to note, however, that the relative relationship between theinternal threads 22 and theexternal threads 24 is not important to the operation of the present invention. In general, thebody 14 of thecap 12 enables the first member to move along the central axis of thebody 14 via one of the set of threads. Thebody 14 of thecap 12 also enables a second member to move along the central axis of thebody 14. It is not important which member moves by engaging theinternal threads 22 and which member moves in the other direction by engaging theexternal threads 24. An important aspect of the present invention, rather, is that two separate members may move inward and outward relative to thebody 14 of thecap 12. - The
inner threads 22 and theouter threads 24 may have any thread pitch desired by the implementor of the present invention. In the illustrated embodiment, theexternal threads 24 are slightly tapered, for example, at about one degree. In an alternative embodiment, the threads are straight, such as in a lead screw or ball screw. In the illustrated embodiment, theexternal threads 24 enable one member to translate relative to another, wherein the member eventually bottoms out or has a limited range of travel with respect to theexternal threads 24. Likewise, theinner threads 22 may be straight threads that allow a member to rotate freely in and out of thebody 14 or theinner threads 22 may be tapered such that the member bottoms out as it inserts into thebody 14. - The
body 14 defines apassage 26 that enables a medical fluid such as a dialysate to move from one end of thecap 12 to another. Thepassage 26 can alternatively be the opening defined by theinner threads 22 and does not have to include the reduced tubing piece illustrated as thepassage 26 inFIG. 1A . Thepassage 26, however, is sized to have approximately the same inner diameter as the tubes or catheters carrying the dialysate back and forth from a dialysate container and the peritoneal cavity of the patient. - In the illustrated embodiment, the
body 14 defines ahousing 28 at an end opposing the internal andexternal threads housing 28 is sized to hold aseptum 30. Thehousing 28 is swaged to theseptum 30 or otherwise holds theseptum 30 in a snug manner. Theseptum 30 cannot move in either axial direction relative to thebody 14. Thebody 14 defines anend wall 32 having a smaller inner diameter than that of thehousing 28, which also holds thecompressible septum 30 in place. A suitable adhesive may also be employed to hold theseptum 30 within thehousing 28. - In an embodiment, the
septum 30 is cylindrical as is thebody 14 and theconnector 10 in general. However, theseptum 30, thebody 14, and theconnector 10 can each have alternative shapes such as being square or rectangular. - The
septum 30 in an embodiment is made of a compressible or rubber material. The septum can be made from any type of rubber, including any of the above listed rubbers. As is well known in the art, theseptum 30 defines a slit (not illustrated) which enables a tube or other type of fluid communication member to pass through aback wall 34 of theseptum 30. Theseptum 30 in the illustrated embodiment generally defines a cap- or nut-shaped rubber or otherwise compressible piece having theback wall 34 and acylindrical side wall 35 that extends from theback wall 34. The nut-shaped or cap-shaped septum in an embodiment is made as one piece, wherein the slit is made in theback wall 34. A tube or fluid communication member then inserts and resides inside a hollow chamber defined by theseptum 30 and at some point is able to pass through theback wall 34. - In the illustrated embodiment, the
connector 10 is configured so that theexternal threads 24 of thebody 14 mate with internal threads of ashell 36. Theshell 36 is a plastic or metal piece and may be of the same material as thebody 14 of thecap 12. Theshell 36 defines theinternal threads 38 that mate with theexternal threads 24 of thebody 14. Theshell 36 can thus translate in either axial direction relative to thebody 14 by rotating in a clockwise or counterclockwise direction about thebody 14. - The
shell 36 defines a tube orport 40, which in an embodiment is integrally formed with theshell 36, e.g., through an injection molding or blow molding process. Thetube 40 extends inwardly into a cavity defined by theshell 36 and into thebody 14 of thecap 12 through an opening defined by theend wall 32 of thebody 14. Thetube 40 also inserts into the cavity defined by theseptum 30. When theshell 36 rotates about theouter threads 24 of thebody 14 to a packaging position, anend 41 of thetube 40 abuts or is directly adjacent to theback wall 34 of theseptum 30. For example, there may be a gap of about 0.010 in. (0.25 mm.) between theend 41 of thetube 40 and theback wall 34 of theseptum 30. - The tube or
port 40 also extends outwardly from theshell 36. The tube orport 40 sealingly connects to a tube (not illustrated) that runs to a dialysate container or a container housing the medical fluid that transfers through theconnector 10 of the present invention. In an embodiment, the tube connecting to the dialysate bag press fits or sealingly fits over theport 40 in such a way that the dialysate does not leak from the interface of the flexible tube running to the dialysate container and theport 40. The tube of the dialysate bag can also connect to theport 40 via a solvent bond. - It should be appreciated that the dialysate is generally transferred back and forth, to and from, the dialysate container under its own weight and generally does not require an external pump or pressure system to drive the flow. Therefore, the fluid is not under substantial pressure and the seal required for the
port 40 is not difficult to achieve. In an alternative embodiment, a hose clamp or other type of releasably fastenable device may be used to bolster the seal made between the flexible tube running to the dialysate bag and theport 40. Such interface is made readily and without requiring the patient or user to have an excessive amount of strength or to perform overly intricate operations. - A
tip protector 42 fits over theshell 36 and at the same time fits into the interior cavity defined by theinternal threads 22 of thebody 14. Thetip protector 42 is made in an embodiment of any of the plastic materials described above. Thetip protector 42 defines a ring or handle 44 that enables the user or patient to remove thetip protector 42 from theshell 36 to begin using theconnector 10. That is, theconnector 10 is initially packaged with thetip protector 42. The first time the user or patient uses thetip protector 42, the user or patient removes the tip protector and discards it. - The
tip protector 42 serves a number of purposes in protecting theconnector 10 prior to use. Thetip protector 42 provides a microbial barrier. Thetip protector 42 disallows bacteria and other harmful airborne agents from entering thebody 14 of thecap 12 prior to use. Just before attaching thecap 12 to a mating connector (seemating connector 60 inFIGS. 2 through 7 ), the patient or operator removes thetip protector 42. In this way, the inside of thebody 14 of thecap 12 is only exposed to open air for a very short amount of time. - In an embodiment, for example, when the
connector 10 is to be used for CAPD, thetip protector 42 also sets theshell 36 at the appropriate distance relative to thebody 14 for packaging theconnector 10. That is, thetip protector 42 helps to set theend 41 of thetube 40 of theshell 36 directly adjacent to theback wall 34 of theseptum 30. - Prior to use, the
tube 40 does not insert into or open up the slit (not illustrated) in theback wall 34 of theseptum 30. However, it is desirable not to have the end of the tube orport 40 too far away from theback wall 34 of theseptum 30 upon packaging theconnector 10 for a couple of reasons. First, it is desirable to package theconnector 10 in as small a space as possible. If theconnector 10 is packaged so that theend 41 resides away from theback wall 34, then theconnector 10 is longer in an axial direction than it needs to be. Second, it is desirable not to make the user or patient rotate theshell 36 more than is necessary to insert thetube 40 through the slit of theback wall 34 of theseptum 30 to begin using theconnector 10. -
FIGS. 1A and 1B illustrate that thetip protector 42 in an embodiment definesthreads 46 that engage some of theinternal threads 38 of theshell 36. Theshell 36 only threads into thetip protector 42 so far before theshell 36 bottoms out against acylinder 48 defined by thetip protector 42.FIG. 1B illustrates that in an embodiment, the outside of theshell 36 includes ataper 35 at the end of the portion of theshell 36 defining thethreads 38. As thetip protector 42 threads into theshell 36, thetaper 35 increasingly presses against the inside of thecylinder 48. In an embodiment, thecylinder 48 of thetip protector 42 defines a steppedportion 47 that facilitates the engagement between thetaper 35 of theshell 36 and thetip protector 42. - Thus, when the
connector 10 is packaged, thetip protector 42 can be placed against or abutted against thebody 14 of thecap 12 before theshell 36 threads onto thebody 14 and onto thethreads 46 of thetip protector 42. Theshell 36 threads over theexternal threads 24 of thebody 14 and passes or translates past the body 14 a desired distance defined by thethreads 46 of thetip protector 42. It is at this point that theend 41 of thetube 40 abuts or is directly adjacent to theend wall 34 of theseptum 30. - It should be appreciated that the
cylinder 48 of thetip protector 42 is not threaded and does not threadingly engage theshell 36 so that thecylinder 48 simply slides over and translates relative to theshell 36. It should also be appreciated that to remove thetip connector 42, the user holds theshell 36 and rotates the ring 44 a number of turns. -
FIG. 1C illustrates an alternative embodiment that is used, for example, when theconnector 10 performs APD. Thetip protector 42 simply slides and possibly slightly press fits onto or into thebody 14 of thecap 12. Here, thetip protector 42 does not define thethreads 46. Theshell 36 may or may not be tapered and may contain a steppedmember 37, wherein themember 37 is intended to slightly frictionally engage the inner wall of thecylinder 48. Theinternal threads 38 of theshell 36 stop before reaching theinner portion 39 of theshell 36 that abuts thetip protector 42. - When the connector is initially packaged, the
body 14 cannot move relative to theshell 36 until thetip connector 42 is removed. This is important to ensure that theseal 18 is not ruptured or displaced prior to using theconnector 10. Thetip protector 42 also includes aninner extension 50 that extends into the chamber created by theinternal threads 22 of thebody 14. Theextension 50 extends so that it abuts or is directly adjacent to theseal 18. This ensures that prior to use, theseal 18 does not loosen and move away from thereceptacle 16 to thereby create aleaky connector 10. Thus, it should be appreciated that thetip connector 42 enables theconnector 10 to be handled and shipped without destroying theseal 18 and/or losing thedisinfectant 20 maintained by theseal 18. - Referring now to
FIGS. 2 and 3 , one embodiment for connecting theconnector 10 of the present invention to amating connector 60 is illustrated. Theconnector 10 may be adapted to operate with many different types of connectors or devices that provide acatheter 62 that inserts into the peritoneal cavity of the patient. In an embodiment, theconnector 10 is adapted to attach to a transfer set that is illustrated inFIG. 2 as theconnector 60. The transfer set in one embodiment is a MiniSet™ manufactured by the BAXTER INTERNATIONAL INC. Although theMiniSet™ 60 is one operable embodiment of the transfer set or catheter device, theconnector 10 can operate with any type of device that couples to a tube or catheter, which inserts into the patient's peritoneal cavity. - In
FIG. 2 , thetip protector 42 is unsecured or removed from theshell 36 of theconnector 10. Theport 40 of theshell 36 of theconnector 10 is illustrated as sealingly connecting to aflexible tube 64 that runs to the dialysate container or bag. -
FIG. 3 illustrates that after inserting theconnector 10 onto the connector or transfer set 60, theshell 36 connected to thetube 64 threads off of and away from thecap 12. Theconnector 10 threads onto the connector or transfer set 60 using theinternal threads 22 defined by thebody 14 of thecap 12, which are exposed when thetip protector 42 is removed. -
FIG. 3 illustrates a point in the process when the patient has completed the transfer of the dialysate from the dialysate container into the peritoneal cavity. Or,FIG. 3 illustrates a point in the process when the patient or user has finished draining spent dialysate from the peritoneal cavity into the dialysate container. In either situation, when theshell 36 threads off of thecontainer 10, thecap 12 of thecontainer 10 remains fixed to the connector or transfer set 60 and thereby caps off the transfer set 60. In this manner, because the sterility ofcap 12 is maintained and cap 12 remains functional, a separate cap which would normally have to be taken off and re-placed onto the transfer set 60 before and after each use is no longer necessary. - Referring now to FIGS. 4 to 7, one embodiment of a method for removing spent dialysate and inserting new dialysate into a patient in a substantially sterilized environment is illustrated.
FIG. 4 illustrates a point in the process when thetip protector 42 has been removed and the transfer set orconnector 60 is ready to be connected to theconnector 10. At this point, the connector or transfer set 60 has not engaged theseal 18 to thereby rupture or displace the seal, which displaces thedisinfectant 20. The connector or transfer set 60 includesexternal threads 64 that mates with the internally facingthreads 22 of thebody 14 of thecap 12. - When the user or patient desires to connect the catheter from the peritoneal cavity to the
connector 10, the user or patient threads the connector or transfer set 60 (connecting to the catheter extending to the peritoneal cavity) into thebody 14 of thecap 12 so that ends 66 of the connector transfer set 60 engage theseal 18 and either move it or rupture it (best seen inFIG. 5 ). That is, the ends 66 apply a translational force to theseal 18 which causes theseal 18 to compress against thedisinfectant 20. Eventually, as the user screws theconnector 60 into thebody 14, the pressure becomes too much for the seal to handle, whereby the seal either moves so that the disinfectant leaves thereceptacle 16 and squirts out around theseal 18 and theends 66 pierce, or the seal ruptures (thin sheet seal embodiment described above) and thedisinfectant 20 runs out over theexternal threads 64 ofconnector 60. - In the illustrated embodiment, the
seal 18 remains intact but moves or displaces thedisinfectant 20 to run out over the outside of thethreads 64 of theconnector 60, so that microorganisms contained thereon are substantially destroyed. Theseal 18 as illustrated may be made in a teardrop-type shape wherein the blunt end of the teardrop has more sealing force than the tapered or sharper end of theseal 18. In this manner, the sharper or tapered end may slightly deform as the blunt end is dragged along the surface of thereceptacle 16. - The
mating connector 60 in an embodiment is sized to engage and slide along thepassage 26 of thebody 14. This also aids in dispersing thedisinfectant 20 onto the outside of themating connector 60 to disinfect the engaging threads. That is, the disinfectant will take the path of least resistance and tend to move into the open cavity defined between the outside of theconnector 60 and an inner wall of thebody 14, rather than squeezing through the friction fit between the inner opening of theconnector 60 and thepassage 26. - Referring now to
FIG. 6 , after the mating connector or transfer set 60 bottoms out against thebody 14, i.e., pushes theseal 18 all the way against thereceptacle 16 ofbody 14. The assembly of theconnector 10 to themating connector 60 is now complete, so that the sealed end of thebody 14 made by theslit septum 30 can be unsealed or opened. To break the seal of theseptum 30, the user or patient rotates the shell orshell 36 relative to thebody 14 wherein the threads of theshell 36 turn against the threads of thebody 14. Theshell 36 thereby translates towards themating connector 60, so that the tube orport 40 of theshell 36 pierces through theback wall 34 of theseptum 30 and through the slit defined by theback wall 34. At this point, fluid communication exists between the peritoneal cavity of the patient and the dialysate bag. - Thus, at the point illustrated in
FIG. 6 , the dialysate fluid may flow in either direction. That is, if the patient is removing spent dialysate from the peritoneal cavity, the dialysate fluid can flow from the catheter in the cavity into themating connector 60, through thepassage 26 of thebody 14, out theport 40 and into theflexible tube 64 running to the dialysate container or bag. - In CAPD, to remove the spent dialysate from the peritoneal cavity, the user or patient typically opens a clamp on the upstream side of the
mating connector 60 or integrally formed with themating connector 60, wherein the spent dialysate runs into an awaiting container. Theflex tube 64 typically runs to a “Y” connection, wherein one leg extends to the spent dialysate container and another leg extends to a new dialysate bag. When the old dialysate has been drained into the spent bag, the operator opens a fill-bag clamp that enables the new dialysate to run from theflexible tube 64, to theport 40, through theseptum 30, through thepassage 26, into the internal diameter of themating connector 60 and into the catheter leading into the peritoneal cavity. With APD, one or more pumps automatically pull the spent dialysate from the patient's peritoneal cavity and places fresh dialysate into same. -
FIGS. 4, 5 and 6 illustrate one complete cycle of flushing old or spent dialysate and replenishing new dialysate into the peritoneal cavity. With both CAPD and APD, the cycle is repeated a number of times. Obviously, many other different types of medical fluids may be substituted for the dialysate described herein, wherein a number of medical procedures may be performed using theconnector 10 having thecap 12 of the present invention. - Referring now to
FIG. 7 , when the transfer of fluids has been exchanged, the user or patient removes theshell 36 from thecap 12, so that thetube 40 of theshell 36 is removed from theseptum 30. When removed, the slit in thewall 34 of theseptum 30 closes and the end of thebody 14 is once again sealed. Thebody 14 remains in the threaded position with respect to themating connector 60, so that thedisinfectant 20 is maintained between the mating threads and the open area between themating connector 60 and thebody 14. - Referring now to
FIG. 8 , animproved end 70 for engaging and movingseal 18 located within adialysate connector 10 a is illustrated.End 70 is contoured to include projections or protrudingportions portions dialysate connector 10 a and transfer set 60 a are mated. Protrudingportions dialysate connector 10 a and transfer set 60 a together to moveseal 18 completely and dispense all or substantially of the disinfectant residing previously withinreceptacle 16 located withindialysate connector 10 a. -
Seal 18 needs to move and/or rupture for the disinfectant to be released from withinreceptacle 16.Seal 18 also needs to survive relatively extreme conditions to whichdialysate connector 10 a is subjected. For example,dialysate connector 10 a may be steam sterilized.Seal 18 must withstand such sterilization or potentially a different type of sterilization.Seal 18 should not be so robust however that a patient with reduced strength and/or dexterity cannot moveseal 18 with relative ease. - Improving the force transfer from
end 70 of transfer set 60 a to seal 18 helps to strike a workable and proper balance. That is, protrudingportions seal 18, which allows for easier displacement of the disinfecting gel located withinreceptacle 16. At the same time, the torque required to assembleconnector 10 a to transfer set 60 a is also reduced. - The non-uniform contour of
end 70 of male threadedportion 68 of transfer set 60 a also tends to preventseal 18 from adhering to end 70. The adhering or sticking ofseal 18 to the end of the transfer set 60 a is more likely to occur if the end ofportion 68 is flat. A flat end is prone to forming one or more negative pressure pocket between the end and seal 18 when forced againstseal 18. Protrudingportions end 70 prevent or substantially prevent such pockets from forming. Further, contouredend 70 including projectingportions seal 18 and end 70 by (i) reducing the pressure generated byend 70 onseal 18 and by (ii) reducing a surface tension betweenseal 18 andend 70. - Protruding
portions portion 68 of transfer set 60 a. While two projectingportions portions portions end 70 are shaped differently to have a desired form. - Referring now to FIGS. 8 to 10, one embodiment for providing a dialysate and transfer set assembly retention and feedback feature is illustrated.
Shell 36 ofdialysate connector 10 a includes ahead 52.Head 52 defines or includes a plurality ofteeth 54 as seen inFIGS. 8 and 10 .Teeth 54 extend at least substantially longitudinally fromhead 52. That is,teeth 54 extend in a direction that is at least substantially parallel to a centerline or line of connection between thedialysate connector 10 a and transfer set 60 a. -
FIG. 9 illustrates that transfer set 60 a includes aring portion 76. For illustration purposes, male threadedportion 68 of transfer set 60 a is removed from transfer setpiece 90 to revealring 76. Arib 78 projects fromring 76. One or more ramps orprojections 80 projects fromrib 78. In one embodiment, a plurality oframps 80 are distributed intermittently about the circumference ofrib 78. -
Ramp 80 includes aninsertion face 82 and aremoval face 84.FIG. 10 illustrateshead 52 ofshell 36 threaded ontoring 76 of transfer set 60 a. Ashead 52 moves longitudinally and radially overring 76,fingers 54 contact andabut rib 78.Rib 78 provides a slight interference fit between transfer set 60 a andfingers 54 ofhead 52 ofdialysate connector 10 a. The slight interference fit helps to preventdialysate connector 10 a from coming loose from transfer set 60 a during treatment.Rib 78 also provides tactile feedback to the patient to signal that the connection betweendialysate connector 10 a and transfer set 60 a is nearing completion. -
Ramps 80 provide a retention benefit as well as feedback to the patient. As illustrated byFIGS. 9 and 10 , when the patient turnsconnector 10 a,head 52 andteeth 54 clockwise aboutrib 78 and ramps 80 of transfer set 60 a, a leading edge ofteeth 54 engages theramp insertion face 82 oframp 80 radially. The angle oframp insertion face 82 provides an increasing amount of tactile feel to the patient. Eventually, thetooth 54 slides completely overface 82 oframp 80 and snaps downward alongface 84 and againstrib 78. Now, the following edge oftooth 54 is locked against ramp removal face 84 oframp 80. The snapping oftooth 54 provides further tactile and potentially audible feedback to the patient. The patient can also visually see that thetooth 54 has moved overramp 80. - It should be appreciated that transfer set 60 a in one embodiment includes a plurality of
ramps 80 and thatmultiple teeth 54 can make tactile and retention contact withmultiple ramps 80 simultaneously, substantially simultaneously or at different times as theconnector 10 a and transfer 60 a are threaded together. Furthermore,multiple teeth 54 will pass over thesame ramp 80, providing feedback over a period of time. - Transfer set 60 a also includes a stop or
shoulder 86. Stop orshoulder 86 preventsconnector 10 a from being over-tightened to transfer set 60 a.Ring 76,rib 78, stop orshoulder 86 and the internal threads illustrated inFIG. 9 can all be made as part of a singleintegral piece 90.Piece 90 in one embodiment is metallic. Alternatively,piece 90 of transfer set 60 a is made of a polymer or plastic. - When the patient is using a CAPD or APD system and is ready to connect
dialysate connector 10 a to the transfer set 60 a, the patient first removes a tip protector, such astip protector 42 shown inFIGS. 1A to 1C andFIG. 2 from the dialysate connector.Tip protector 42 is removed from theshell 36 ofconnector 10 a. Removing such tip protector exposes thehead 52 andteeth 54 ofshell 36 ofdialysate connector 10 a. - Next, the old cap (from the old dialysate connector) is removed from the transfer set. For example,
FIG. 3 shows cap 12 connected to transfer set 60. As described herein, adialysate connector 10 initially housescap 12. Onceshell 36 is pulled away from a transfer set 60,cap 12 remains on the transfer set. To insert anew dialysate connector 10, the previously usedcap 12 is removed. The transfer set 60 (referring collectively to set 60 a, etc.) is then inserted into the dialysate connector 10 (referring collectively to set 10 a, etc.). Asset 60 andconnector 10 are threaded together, clicks are heard, felt and seen whenteeth 54 engage and snap over the protrusions or ramps 80 located on therib portion 78 ofring 76. - In an embodiment,
ramp removal face 84 is also angled although at a different angle thanramp insertion face 82. To removeshell 36 from transfer set 60 a, theteeth 54 are rotated counterclockwise over the differently angled, e.g., moresteep ramp face 84. The pitches or angles of thefaces projections 80 result in a desirable insertion and removal torque, e.g., for patients having poor dexterity and low strength. - When a connection between the
dialysate connector 10 a and transfer set 60 a is completed,projections 80 rest between gaps located betweenteeth 54, lockingshell 36 in place and preventing free rotation of same. Such feature minimizes inadvertent separation of theconnector 10 a and set 60 a if forexample connector 10 a and/or transfer set 60 a are placed under stress. - The present invention includes a number of alternatives to the embodiment illustrated in FIGS. 8 to 10. First, projections or ramps 80 may be located in any frequency about
rib 78 ofpiece 90. There may be oneprojection 80 for everyseveral teeth 54, oneprojection 80 for every couple ofteeth 54 or one projection for eachtooth 54, for example. In an embodiment,projections 80 are provided in a sufficient frequency to produce a ratchet-type connection, in which the patient feels and/or hears multiple clicks as the two pieces are threaded together. In an embodiment, theramp projections 80 are provided back to back or virtually back to back so that in essence,rib 78 becomes a ring of rampedprojections 80. Alternatively,rib 78 is not provided. Instead, a series ofprojections 80 extends directly from the diameter ofring 76. -
Projections 80 may have any suitable shape and are not limited to the ramp faces 82 and 84 shown inFIG. 9 .Projections 80 may for example be gear-shaped, generally rectangular, generally triangular, have one or more curved edges and/or one more angled edges. The angles and/or curves are chosen to provide a desired amount of resistance that balances the need for a retention force and tactile feedback with the fact that persons with limited strength may be assemblingconnector 10 a to the transfer set 60 a. - In a further alternative embodiment, a ramped shaped projection is provided, however, the ramp projects longitudinally upward from
ring 76 towardsstop 86 instead of radially up and down as shown inFIG. 9 . In still a further alternative embodiment,shell 36 provides inwardly facing teeth andring 76 orrib 78 defines indents or detents that mate with such inwardly facing teeth. - Referring now to
FIG. 11 , analternative dialysate connector 10 b and an alternative transfer set 60 b are illustrated. Theconnector 10 b and transfer set 60 b provide a ratchet-like tactile feedback to the user or patient.Dialysate connector 10 b includes ahead 52, likeconnector 10 a of FIGS. 8 to 10. Here, however,head 52 includes or defines a plurality of outwardly extending ratchet-like projections 56.Projections 56 are provided in lieu of thelongitudinally extending teeth 54 ofconnector 10 a in FIGS. 8 to 10. - Transfer set 60 b includes a
piece 90 having aring portion 76.Ring portion 76 includes or defines a plurality of inwardly facing ratchet-like projections orteeth 88. Inwardly facingprojections 88 mate with outwardly extendingprojections 56 in a ratchet-like manner to provide tactile feedback to the user or patient, e.g., to let the patient know that a connection betweenconnector 10 b and transfer set 60 b is almost or totally complete. The ratchet-like connection also provides a retention force to help hold theconnector 10 b and transfer set 60 b together when mated. - In an alternative embodiment,
dialysate connector 10 b may include inwardly facing ratchet-like teeth, while the transfer set 60 b includes or defines outwardly facing ratchet-like teeth. The ratchet-like teeth may be generally triangular in cross-section or have any suitable cross-sectional shape. - Referring now to
FIG. 12 , a further alternative embodiment of the present invention is illustrated bydialysate connector 10 c and transfer set 60 c. For convenience, the relevant portion ofshell 36 ofdialysate connector 10 c and a relative portion of transfer set 60 c are illustrated.Shell 36 of transfer set 10 c includes a plurality of inwardly facingprojections 58 a to 58 c.Projections 58 a to 58 c may or may not be part of a thread that threads onto mating threads of transfer set 60 c. - In the illustrated embodiment,
projection 58 c extends inwardly and annularly withinshell 36 ofconnector 10 c.Projection 58 c is oriented in an embodiment in a plane that is substantially perpendicular to a center ofaxis 92 extending through transfer set 60 c andshell 36. That orientation enables an undercut 94 formed inprojection 58 c to ride along aprojection 96 extending outwardly frompiece 90 of transfer set 60 c. Undercut 94 includes a female contour that at least substantially matches a male contour of outwardly extendingprojection 96. - In operation, shell 36 of
connector 10 c threads onto transfer set 60 c until undercut 94 ofprojection 58 c mates with outwardly extendingprojection 96 ofpiece 90 of transfer set 60 c.Piece 90 of transfer set 60 c also includes ahardstop 98 that precludesshell 36 from being over-tightened, in which case undercut 94 could spin off of outwardly extendingprojection 96. The interface between undercut 94 andprojection 96 provides tactile feedback to the patient or user. Additionally, the mated pieces help to holdshell 36 in place with respect to transfer set 60 c when fully mated onto the transfer set. - Referring now to
FIG. 13 , a further alternative embodiment of the present invention is illustrated bydialysate connector 10 d and transfer set 60 d. For reference,tube 40 andseptum 30 described above are shown. In this embodiment,shell 36 includes a plurality ofarms Arms shell 36 viastandoffs 106.Standoffs 106 provide pivot points upon whicharms FIG. 13 ,arms user presses arms standoffs 106. Such action causes the distal ends 108 ofarms shell 36 andconnector 10 d can be unthreaded from transfer set 60 d. - When
connector 10 d is engaged with transfer set 60 d, the user threads shell 36 over transfer set 60 d until the distal ends 108 ofarms arms transfer 60 d. Although twoarms - The snap-fitting of
arms shell 36 on the transfer set 60 d until the patient presses the arms and twists shell 36 off of the transfer set. -
Dialysate connector 10 d provides a further advantage.Arms tip protector 42 in place so that it cannot inadvertently come loose from the open edge ofconnector 10 d. ViewingFIG. 1A and imaging arms extending from right to left alongshell 36, it should be appreciated that the arms can be configured to snap-fit over thecylinder 48 oftip protector 42 to holdtip protector 42 in place. When the patient wishes to removetip protector 42 from the connector, the patient pressesarms distal ends 108 of the arms fromcylinder 48 oftip protector 42. The patient removestip protector 42 from the connector with the patient's other hand. - Referring now to
FIGS. 14 and 15 , another embodiment of the present invention is illustrated by snap-holdingcollar 110.FIG. 14 illustrates that snap-holdingcollar 110 includes afirst portion 112 that snap-fits over thehead 52 ofshell 36. Asecond portion 114 ofcollar 110 snap-fits over thering portion 76 of transfer set 60. Snap-holdingclip 110 holds theconnector 10 and transfer set 60 together after they have been mated so that the two cannot come apart during therapy. In the illustrated embodiment,collar 110 is a piece formed separately fromconnector 10 and transfer set 60. - In an alternative embodiment, clip or
collar 110 is fixed permanently to transfer set 60. Here, viewingFIG. 15 , thecollar 110 would slide left to right to snap-fit over a projection orindentation 116 defined byshell 36. The slidingcollar 110 is flexible enough to be pulled away fromshell 36 when the shell needs to be removed from transfer set 60. The indentation ofprojection 116 can be made small enough and/orfirst portion 12 can be made pliable enough so that removingcollar 110 in a sliding manner is not overly difficult. - In either the separate piece or sliding collar embodiments,
collar 110 provides feedback to the patient that theconnector 10 and transfer set 60 are fully mated. That is,collar 110 will not fit properly ifconnector 10 and transfer set 60 are not mated properly. Also,collar 110 helps to holdconnector 10 and transfer set 60 together after they are fully mated. In thiscapacity collar 110 serves a retention function. - Referring now to
FIGS. 16 and 17 , other embodiments of the present invention are illustrated. Both embodiments ofFIGS. 16 and 17 employ a gasket. Also, both embodiments employdialysate connector 10, such asconnector 10 shown inFIGS. 1A and 2 to 7. The connector ofFIG. 16 provides agasket 120 that is compressed inwardly aboutring portion 76 of transfer set 60 e. Alternatively, shell 36 inFIG. 17 compresses gasket 122 longitudinally against astop 124 extending radially fromring portion 76 of transfer set 60 f. - In
FIG. 16 ,gasket 120 is housed within anannular groove 126 defined inring portion 76 of transfer set 60 e. As illustrated,gasket 120 in an embodiment is an o-ring type gasket. Alternatively,gasket 120 is flat in cross-section or has any suitable cross-sectional shape. -
Gasket 122 inFIG. 17 is housed within a shallow well defined bystop 124. In the illustrated embodiment,gasket 122 has a flat washer-type shape. In an alternative embodiment,gasket 122 has any suitable o-ring or cross-sectional shape. -
Gaskets shell 36 onto transfer sets 60 e and 60 f, respectively. Moreover,gaskets - It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
Claims (29)
Priority Applications (14)
Application Number | Priority Date | Filing Date | Title |
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US11/046,306 US7708714B2 (en) | 2002-02-11 | 2005-01-28 | Dialysis connector with retention and feedback features |
PL05818479T PL1841495T3 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
EP05818479A EP1841495B1 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
MX2007009026A MX2007009026A (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features. |
DE602005018109T DE602005018109D1 (en) | 2005-01-28 | 2005-10-24 | DIALYSIS CONNECTOR WITH HOLD AND FEEDBACK FEATURES |
AU2005326922A AU2005326922B2 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
AT05818479T ATE450291T1 (en) | 2005-01-28 | 2005-10-24 | DIALYSIS CONNECTOR WITH HOLDING AND FEEDBACK FEATURES |
BRPI0519954-9A BRPI0519954A2 (en) | 2005-01-28 | 2005-10-24 | dialysis connector with retention and feedback characteristics |
DK05818479.7T DK1841495T3 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback means |
JP2007553089A JP4527785B2 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
KR1020077017304A KR20070095983A (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
ES05818479T ES2337707T3 (en) | 2005-01-28 | 2005-10-24 | DIALYSIS CONNECTOR WITH RETENTION AND FEEDBACK FUNCTIONS. |
PCT/US2005/038424 WO2006083333A1 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
CA002595827A CA2595827A1 (en) | 2005-01-28 | 2005-10-24 | Dialysis connector with retention and feedback features |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/074,532 US7198611B2 (en) | 2002-02-11 | 2002-02-11 | Dialysis connector and cap having an integral disinfectant |
US11/046,306 US7708714B2 (en) | 2002-02-11 | 2005-01-28 | Dialysis connector with retention and feedback features |
Related Parent Applications (1)
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US10/074,532 Continuation-In-Part US7198611B2 (en) | 2002-02-11 | 2002-02-11 | Dialysis connector and cap having an integral disinfectant |
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US20050197646A1 true US20050197646A1 (en) | 2005-09-08 |
US7708714B2 US7708714B2 (en) | 2010-05-04 |
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US11/046,306 Expired - Fee Related US7708714B2 (en) | 2002-02-11 | 2005-01-28 | Dialysis connector with retention and feedback features |
Country Status (14)
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US (1) | US7708714B2 (en) |
EP (1) | EP1841495B1 (en) |
JP (1) | JP4527785B2 (en) |
KR (1) | KR20070095983A (en) |
AT (1) | ATE450291T1 (en) |
AU (1) | AU2005326922B2 (en) |
BR (1) | BRPI0519954A2 (en) |
CA (1) | CA2595827A1 (en) |
DE (1) | DE602005018109D1 (en) |
DK (1) | DK1841495T3 (en) |
ES (1) | ES2337707T3 (en) |
MX (1) | MX2007009026A (en) |
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WO (1) | WO2006083333A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
WO2006083333A1 (en) | 2006-08-10 |
EP1841495B1 (en) | 2009-12-02 |
AU2005326922B2 (en) | 2010-11-18 |
PL1841495T3 (en) | 2010-07-30 |
EP1841495A1 (en) | 2007-10-10 |
US7708714B2 (en) | 2010-05-04 |
BRPI0519954A2 (en) | 2009-04-07 |
AU2005326922A1 (en) | 2006-08-10 |
MX2007009026A (en) | 2007-09-14 |
DK1841495T3 (en) | 2010-03-08 |
CA2595827A1 (en) | 2006-08-10 |
DE602005018109D1 (en) | 2010-01-14 |
JP4527785B2 (en) | 2010-08-18 |
ES2337707T3 (en) | 2010-04-28 |
ATE450291T1 (en) | 2009-12-15 |
JP2008528173A (en) | 2008-07-31 |
KR20070095983A (en) | 2007-10-01 |
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